“Director of Hemato-Oncology at Hospital Clínic de Barcelona Advocates for Common European Transparency Framework for Hospital Exemption of Advanced Therapies”

access to advanced therapieslike the CAR-Tbecomes very restricted between the European countries because of his high cost or for the bottleneck that generates your production. Against this background, the hospital exemption has become a as valuable to break this dynamic, and one of the proposals put forward by the Spanish Network of Advanced Therapies (SHARP) is the making of a European public registerwith the purpose of creating a common transparency framework, security y trust between the different countries.

Establishing equal criteria for all European countries with regard to hospital exemption is defended by Alvaro Urbanodirector of the Institute of Hemato-Oncology of the Clinical Hospital of Barcelona and member of TERAV in Medical Writing: “There must be a common European standard, more detailed and that defines the requirements so that an exemption can be proven for a certain product. In this way, it will avoid being as lax as it is up to now, since each country has its measuring stick. There is a common denominator for all countries, and that is that the product is not industrial and that it must take place in a hospital that has been approved for that indication. Then, there are criteria that are left to the judgment of each regulatory agency, such as whether to carry out a clinical trial, evaluate the preclinical or not, etc.”

Urbano gives as an example to follow the current highly demanding Spanish model at the European level: “The fact that the Spanish Agency for Medicines and Health Products (amemps) demands many requirements is synonymous with quality. All European countries can carry out this clause, but some of them demand less or directly they do not require them. An exemption can be started directly without having done a rigorous clinical trial, as is the case in Spain”.

The journey that the CAR-T ARI 0001 demonstrates why hospital exemption in Spain is, in the words of the hematologist, “one of the more complete, since it resembles the requirements requested by the European Medicines Agency (EMA). The Aemps has been in charge of carrying out the first screening assessment, and after achieving the assessment Prime by the European agency, the CAR-T is in the process of achieving its accelerated evaluation”.

Scientific societies, key in the exemption

When it comes to harmonizing as much as possible a common hospital exemption within the Old World, Urbano considers that they should be the european commissions and the regulatory agencies who “must agree to achieve it”, although he also highlights the role of scientific societies: “These organizations have agreed on a series of demands, such as how they are different international accreditations in Europe in relation to transplant centers. It is a self demand, identical to the American accreditation system, and there is no agency that forces us to do so. The companies themselves can be the ones that impose common regulations at the European level, in addition to the agencies themselves”.

Encourage the hospital exemption in Europe is, as the hematologist considers, the future for advanced therapies approach the patient: “These are drugs with very high costs, and that causes there to be countries that do not approve them. Access to it is very limited for different reasons, so making the exemption universal is key to bringing innovation to the patient”.