Polish industrial innovators will now be able to apply for patents online and the process will be shortened from 18 to 6 months, according to the Ministry of Enterprise, while drug companies will be able to bring generic drugs onto the market faster, say medical experts.
Changes to Polish patent law, which was signed by Andrzej Duda on Wednesday evening, bring the regulations closer in line with EU norms, particularly regarding the protection of drug patents, the medical website Medexpress writes.
The new patent laws include the “Bolar exemption”, which will enable generic drug companies to carry out testing on drugs for which the patent is about to expire.
At present, generic producers have to wait until the expiry of a patent before starting clinical tests, which can lead to a delay in bringing their products to market for several years.
The Polish pharma market was worth over PLN 15 bn (EUR 3.5 bn), roughly the equivalent of one percent of the Polish GDP in 2017. The manufacturers are mostly generic drug producers. The main players are Nueca, Farmacol, Tzmo, Polpharma, Hurtap, Adamed, Medicare, Biofarm and Jelfa.
The ability to get drugs to market faster will ensure domestic producers will be better able to compete with foreign imports of generic drugs. Presently several countries apply the Bolar exemption, including the UK and Germany.