The route for the new drug to reach the patient is longer than before. In addition to the delays caused by the Ministry of Health, which according to the latest data from the waiting report amount to 629 days, we now have to add 150 more days that the Autonomous Communities are consuming through the reassessments they are making following the decision of the Central Government. An increase of 25%, bringing the delay in Spain to an average of 779 days since the European Union confirmed the validity of the drug.
However, from the pharmaceutical company’s perspective, the time from the successful completion of clinical studies to the patient benefiting from the therapy innovation is even longer. Specifically, it is 1,056 days (almost three years).
The European Medicines Agency needs an average of 210 days to complete the scientific evaluation of the new medicine. To this seven-month period we must add 67 days that the European Commission normally needs to give the health organization’s decision the necessary legal basis. From this moment on, the Spanish odyssey begins, completely dissolving the files in an average of 2.1 years.
The situation that currently exists is a scissors situation. Pharmaceutical companies have twenty years of patent time to use their products, but the average research time is about ten years. If you add 1,056 days (2.9 years) to this period, the actual useful life of your innovation is just over seven years. If we add to this the claims of the European Commission, which in its new pharmaceutical strategy proposes a reduction of the patent term by two years, the ability of the pharmaceutical industry to make research profitable will be severely limited.
Fatal consequences
The consequences have been felt in recent years at the European level, while at the national level companies have made a final attempt at communication. At the community level, China has seen a surge in investment in new drugs in oncology, one of the pharmaceutical industry’s main business areas, over the past year, according to data from consultancy Iqvia.
Over the last 15 years, European activity has declined by five percentage points, from 26% of the oncology portfolio to 21%. Meanwhile, the Asian giant has exploited its full potential, especially in the last five years, and managed to dethrone Europe for the first time. China now accounts for 23% of the catalog, compared to 10% five years ago and 5% ten years ago. If the patent reduction is completed, many pharmaceutical companies have already warned that the investments will flow into other markets.
For their part, at national level, companies have offered the government 8 billion euros in investments in both clinical trials and production facilities in return for improving legislation so as to shorten the 779 days that pass since European approval. A year ago, the Ministry of Health committed to reforming the drug law, but failed in its attempt to implement this before the end of the legislative period. As a patch, two royal decrees were announced to mitigate the delays, but these have not yet seen the light either.
