Fulfilling these conditions would render pharmaceutical companies eligible for regulatory incentives, which include marketing the authorised medicinal product in all EU member states, developing medicines that address unmet medical needs, conducting comparative clinical trials, and creating medicinal products with additional therapeutic indications (repurposed medicines).
On the other hand, the Commission recommends reducing the regulatory protection granted to ‘ordinary’ medicinal products from eight to six years, aiming to expedite the availability of generic and biosimilar medicinal products in the market. This approach signifies a shift away from a ‘one-rule-fits-all’ strategy towards a more flexible framework that rewards companies dedicated to achieving the EU’s priority objectives of safeguarding public health.
Presently, manufacturers introducing innovative drugs to the market enjoy eight years of regulatory data protection and market exclusivity, with an additional two years of market exclusivity (resulting in a total of 10 years). If a new therapeutic indication is developed, an extra year of protection is granted. This system is commonly known as the ‘8 + 2 + 1’ formula.
The proposed provisions envision a general reduction in the period of regulatory data protection and market exclusivity from eight to six years (although the proposed text is likely to undergo amendments during the ordinary legislative procedure involving the Council and the European Parliament). An extra two years would be added if the concerned medicinal product is marketed in all EU member states – unless specific member states declare their lack of interest in marketing the medicine within their territories, thereby opposing an extension.
