shorter patents on medicines. Strong push towards “generic” products to avoid shortages

Europe launches the single market for medicines to improve access to care and avoid the shelf shortages seen in recent months. But the pharmaceutical reform that the EU executive presented yesterday with dissatisfied industry, which fears finding itself without the tools to innovate and be able to compete with companies of Chinese and United States. The approach chosen by Brussels, which has been working on the package for over three years, is that of the carrot and the stick: the protection of intellectual property rights on drugs as a rule, it is reduced from ten to eight years, but it can expand again if the manufacturer decides to guarantee uniform access to the medicine in all the states of the Union within two years of its placing on the market. Shorter patents then. And push towards generic drugs to have more and more products available.

Free contraceptive pill for all women of all age groups, the decision of Aifa

THE STAGES

Innovative therapies that meet hitherto unmet medical needs and studies that produce comparative clinical data are also protected from the EU trap on the duration of data protection: in these cases, the pharmaceutical house he may add further shots up to a maximum of 12 years of protection. In short, this is the incentive system with which Brussels wants to compensate and keep industries in Europe. Also because, explains the EU executive, the EU “will continue to offer one of the most attractive regulatory contexts in the world“, providing levels of protection equivalent or superior to those of Japan, Canada, Israel and China. “The construction of the single market for medicines is a necessity for everyone, citizens and businesses”. Stella Kyriakides, the EU health commissioner, quoted Bono of U2 to condense the sense of the reform: “The place where you live must not be able to determine whether you will live or die”. A problem that cuts Europe in two: if in the richest countries it is possible to have access to 90% of the new drugs approved by the independent authorities, in the east and in the smallest states this number is drastically reduced to 10%, added Kyriakides . With long wait times ranging anywhere from four months to two years.

I TARGET

“With our incentives, we will be able to provide new medicines to about 70 million more people than today. Innovation must reach patients to have value for society.” In the EU plans, there is also the simplification and acceleration of authorization procedures and a more rapid diffusion of generic medicines, as well as the development of electronic package inserts which will go alongside paper liars and the development of a list of medicines critical to have in stocks to prevent crisis situations. The companies are preparing to do battle now that the executive’s proposal will have to be negotiated by MEPs and governments before final adoption: for Efpia, the European Pharmaceutical Federation, the strict regulation “risks sabotaging our industry”, setting ” impossible goals”.

Read the full article
on The Messenger