In recent months, the debate on patent effects on the cost of medicines and, at the end, on the very sustainability of public health systems has been taking place in Europe and the United States.
Although it is true that patent system can provide incentives for innovation, on many occasions, it has led to a considerable increase in the cost of medicines which can ultimately affect patient access.
This happens because in many cases this system does not help innovation but rather the monopolization of existing drugs. According to estimates, between 78 and 80% of new patent applications are not for new medicines.
Recently, in an article in the Journal of Law and the Biosciences, a group of researchers has stated that the cost of prescription drugs is growing faster than any other form of expense related to medical care, including hospitalization.
In the EU, protection formally lasts 20 years. However, due to the long process of registering medicines before market approval, it is possible to extend the original patent for up to five years through a supplementary protection certificate (SPC). In the United States, an analysis of the ten best-selling medicines of 2019 reflects that they have 69 patents with 37.5 years of patent protection, much more than the expected. And the effect on prices is immediate: those same medicines increased their price by 71% in the last five years.
Actual patent system, at its core, still is a good system to promote innovation, but it is necessary to introduce reforms that benefit its simplification, transparency, access to information and, in the case of the EU, harmonization between countries. Also, to support the use of off-patent medicines, such as biosimilars and generics, which will allow significant savings for the countries. Introducing these reforms, will contribute to the sustainability of public health systems and, ultimately, benefits patients’ access to their treatments.