Manufacturing waiver (SPC MW) and its impact on the public interest in scope of public health.

Abstract

The length of innovative medicinal product protection time is related to the economic interest of the pharmaceutical companies and the interest in public health. To perform the tasks of patent protection of medicinal products, bearing in mind the interest in the field of public health, its maximum length must be determined by law. Due to the applicable law, the actual term of protection of innovative medicinal products is extended to the benefit of producers of innovative drugs. Regulation (EU) 2019/933 of the European Parliament and of the council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products introduces a legal instrument, supplementary protection certificate manufacturing waiver (SPC MW), implementing the limits of the maximum duration of legal protection granted based on the supplementary protection certificate (SPC). According to estimated data, SPC MW may bring savings of the European public health sector in the amount of EUR 3.1 billion and savings of the National Health Fund in the amount of PLN 500 million annually. However, a final assessment of the economic and social impact on public health will only be possible after the entry into force of the new legal instrument.