From the moment a molecule with curative potential is discovered until it becomes part of an available medicine, between ten and thirteen years can pass. In addition, according to the pharmaceutical industry employer in Spain, Farmaindustria, out of every 10,000 molecules investigated, only one reaches the market.
But in times of pandemic, it is time to accelerate the processes . This is why companies that have drugs that could work against SARS-CoV-2 have put the machinery in motion – and at a hellish rate – to test their safety and efficacy and see which ones have a chance. But before a drug is marketed, it must pass all the demanding phases of clinical trials.
Before testing in humans, there is a preclinical phase to see what effects the compound has on animals. If it is safe and effective, it begins to be administered to people and more and more participants are recruited to ensure that the observed benefits are given equally in all population groups. In the current circumstances, stages are overlapping to buy time, while regulatory agencies continue to review the data as it is obtained. One of the pending issues in Europe is to catch up to ensure that the drugs developed in the continent have the same possibilities as those in other countries.
According to Dr. Tomás Olleros, president of the Farmasierra pharmaceutical group, “the COVID-19 pandemic has highlighted the risk that Europe runs by not authorizing new products at the required rate: losing competitiveness against the United States and Asia.” For this reason, he points out, “the European Federation of the Pharmaceutical Industry has launched a roadmap to accelerate innovation and especially the authorization of new drugs . Regulatory processes will be streamlined without losing the guarantee of quality and effectiveness and within the current legislative framework ”. Only in this way will paperwork be minimized so that the remedies they need reach patients soon. It is also expected that, despite the reduction in time, additional requirements will be established to help confirm whether a drug is suitable or can be applied to other diseases beyond those for which it was already approved .
Regarding the specific manufacture of drugs for clinical trials, the doctor points out that “the process will have to be more efficient so that they can demonstrate their validity and safety in the face of a new disease in less time, and this will require improving the training of the employees of the pharmaceuticals ”. Olleros adds that the sector must “work much more in prevention and prepare for emergency situations, and that requires more resources and developing contingency plans.”
By Nieves Sebastián
