A few years ago, the European Medicines Agency called the Spanish Agency for Medicines and Health Products (AEMPS) to ask what was the secret behind why biomedical research works so well in Spain and so many clinical trials are being conducted. “We tell you today José María Moraleda, Coordinator of RICORs TERAV of the Carlos III Institute of Health (ISCIII), that this is the involvement of the State, Science and Health Ministries in advanced therapies. It is translated, for example, by A A platform of cell proliferation rooms spread across the country This allows us to carry out tests, due to public funding (even if it is fair), to carry them out with a network of hospitals that collaborate to carry out these (cheap) studies, and finally to have a great collaboration. Relationship with AEMPS. This set means we could have that lead.”
Problem? As a country we are staying there, continues the head of service at the University Clinical Hospital of Murcia Virgen de la Arrixaca. In phase I (out of three) clinical trials, when the potential of a possible product (medical device, treatment, drug) begins to be evaluated, but is still far from reality, serving as something practical and on the market.
We are leaders who generate ideas, say those in the know, but we don’t produce them. “Because we don’t know the business. We have no idea how to transfer this knowledge to medium or large scales. It is a barrier, a barrier that damages the country’s potential industrial fabric. There, ideas remain hidden that are not fully realized,” he says.
It is left to others, usually large foreign pharmaceutical companies, who eventually recognize and receive the money generated, at least in part, by publicly funded research. And then it’s time to buy these patents at a high price to make them available to the public, for which the state pays twice for the same thing.
When the product has a possible use and can be finished in industry, the scientist has already completed his work, which is creative. It is in the hands of the companies. And in Spain it fails miserably because we have very little industrial fabric
This diagnosis is shared among professionals in the sector. Damian García Olmo, Head of the Department of Surgery at the Jiménez Díaz Foundation and Professor of Surgery at the Autonomous University of Madrid (UAM), briefly explains how this process usually takes place: “In Spain, there are fantastic ideas from very creative people and the first phases of development usually take place in academia, in universities, in the public world . These are very fair funding phases and when it seems possible to apply and it can end up in industry, the scientist (again: usually public, from universities) has already completed his work, which is creative and not industrial. . It is in the hands of companies, industrial fabric. And it fails miserably in Spain because we have very little fabric. There are very few companies in the sector. then, [con el trabajo del científico ya realizado y sin capacidad de ir más allá]We present ideas [porque los científicos necesitan y quieren publicar para hacer currículum]. A patent is issued or pending [de una idea prometedora pero sin desarrollar] which is sold for very little money and the investment is not returned to the public system.
“Private companies sell at excessive prices in their market”
The organization Salud por Derecho, which recently conducted a study on the situation, summarizes what is finally happening. “Unfortunately, in most cases, the final products are later sold by private companies at exorbitant prices, making them huge profits.” How to ensure the performance and social return of public investments remains a major challenge for all funders and public research institutes,” the organization explains.
in the report Licensing and Access to Health Technologies: Overcoming Barriers to Return on Public Investment in Research and Development It is explained that a variety of factors influence the choice of the type of patent that applies to a product. The nature of the product developed or the specific situation of the particular sector in which it enters are two of them.
“The theory is that innovation in an embryonic state requires an exclusive license to attract private investment. [para desarrollar el producto]While innovations that are more general or advanced can be openly licensed,” they explain, to automate immediately, adding that other studies point more decisively to “the transfer offices’ lack of capacity, market knowledge, or financial constraints,” among others.
Like the professionals, the Ministry of Science also found the problem and corrected the proposal. Minister Diana Morant has announced that a public-private commercial company will be created to carry out this work of developing medicines or products, so that public investment is not wasted. The Ministry does not provide much information about this future company at the moment: “The government intends to create a mercantile company with Spanish pharmaceutical companies to accelerate the market entry studies that are being carried out in Spanish science. system and that citizens (or national health systems) can benefit from it by guaranteeing universal access through public-private cooperation,” explained department sources.
Although there is almost no information about this community at the moment – publicly, at least – the actors involved in the investigation believe that it is more than necessary. “Personally,” Moraleda breaks away from her institutional position for a moment, “I think it’s necessary. They should help us instead of giving everything to the pharmaceutical companies that go back to the Spanish state.
“We can’t afford it”
Patent licensing becomes more expensive as product research and development progresses. It could cost around 15,000 euros in the first year, 20,000 in the second and could reach six figures in the more advanced stages, sources familiar with the processes explained.
“We cannot pay for this with university funds,” explains Garcia Olmo. This is where OTRIs (Offices of Transfers) came in, where campuses negotiate with companies that will later develop products once they demonstrate their potential. “We just hope they negotiate well” to return the commercialization to the university.
García Olmo, one of the leading researchers in the country, tells us his recent success story: “We found a way to treat rectal cancer stroma with a substance called collagenase, which we patented, and the company COMBAT – which is dedicated to the production of these treatment devices – reached an agreement with Jiménez Díaz with the Foundation and UAM. They pay the costs, they are responsible for maintaining the patent, which is an incredible exemption for us, but the patent holder is UAM, which receives Royalty For the medicine we developed. we [su equipo tiene una decena de patentes en el mercado] We’re very excited when they buy from us because it means it’s coming back to our facility.”
While this community is being formed, other initiatives are emerging. Last Thursday, CERTERA was presented, a consortium of the Carlos III Health Institute to create advanced therapies with the same philosophy as a company that wants to create science. Minister Morant announced in an event organized by elDiario.es that he will be awarded 45 million euros. “We need to strengthen the system of clinical or pre-clinical phase hospital therapy developed in the centers, which already exists,” explained the minister. Moraleda believes that “Incorporate into PERTE [los Proyectos Estratégicos para la Recuperación y Transformación Económica] Something scientific and technological is one of the relevant achievements of the Ministry. This is a paradigm shift in terms of innovation.”
Both Moraleda and García Olmo believe that Spain needs to promote public-private collaboration to develop this type of research. ” gap [el agujero] It is a communication between academia and companies. Many times they try to solve it in a funny way, which means that researchers or universities are going to produce something. That’s not how it works. The world works in such a way that in order to invent something to reach the public or the patient, a business fabric is needed, but in Spain, because of the surprising (in this sense) history that we have, there is hostility to the creation of companies, businessmen and public-private cooperation are demonized”, laments García.
“We are in favor of public-private collaboration, but with a substantial twist in society, because we do the most difficult part,” agrees Moraleda, referring to creativity and making something out of nothing versus developing an idea that has already been worked on.
Source: El Diario