The Supplementary Protection Certificate (SPC) is a sui generis protection that extends the market protection of patented medicines by up to five and half years (including a paediatric extension) to compensate the time lost in obtaining regulatory approval of medicines. As such, the European Union protection is the longest in the world.
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Medicines for Europe, the European off-patent medicines association, and CAFF, the Czech generic and biosimilar medicines association, have organised under the auspices of the Czech Presidency of the Council of the European Union a seminar on 10 November 2022 entitled “Ensuring equitable and sustainable access to medicines through a secure and resilient supply”.
The event has been organised in line with the main objectives stated in the European Commission pharmaceutical and updated industrial strategies for Europe, which have been published setting up clear goals for the European Union that delivers on access, availability and affordability while achieving a great open strategic autonomy, also taking into account the Covid-19 pandemic lesson learned.
Biosimilar medicines are biologic medicines that can be used safely and effectively in oncology and other therapy areas. Some of these medicines are so important that they are included in the WHO essential medicines list.
More than 15 years of experience with biosimilar medicines show us that these medicines can be used to expand access to treatment, as they are just as safe and effective as their originator counterparts and can therefore be considered interchangeable with them.