Patents and Supplementary Protection Certificates offer the most significant form of protection for new medicines. However, the various forms of regulatory exclusivity available in different countries can also be key. Current EU medicines reforms will see extensive changes to these non-patent forms of protection, although remaining largely favourable to innovators overall.
The new EU pharmaceutical legislation reform package (the Pharma Package) includes extensive changes to these forms of protection.
New active ingredients: 8 + 2 (+1) will become 8 + 1 (+1) (+1)
The current 8 + 2 + 1 system provides eight years of data protection during which time generic or biosimilar producers may not rely on the regulatory data package associated with the originator product, as well as two years of market protection during which the generic or biosimilar product may not be launched. An additional year of market protection is available where the marketing authorisation holder has obtained marketing authorisations for additional indications during the first eight years.
Under the new system, eight years of data protection will be available, with one year of market protection as standard. An additional year of market protection will be available where a new indication is approved during the data protection period.
A further year of market protection is available in certain circumstances, including where:
- The medicine meets an unmet medical need (a life-threatening or severely debilitating disease) and either there is no available authorised treatment, or the medicine offers a clinically relevant improvement in efficacy, or in safety with at least comparable efficacy, over authorised treatments
- One of three tests relating to the conduct of clinical trials in more than one EU country, and the application for marketing authorisation in the EU being the first internationally or soon thereafter, is met
The total available period of protection can therefore amount to 11 or even 12 years in the most favourable scenario.
In addition to this reworking of the existing incentive packages for innovators, two new kinds of protection will be available under the Pharma Package.
Transferable exclusivity voucher for antimicrobials
Addressing antimicrobial resistance is recognised as a priority issue and one that requires additional support, given the relatively low sales volumes for this product category. The transferable exclusivity voucher (TEV) offers a targeted incentive by providing an additional year of market protection for priority antimicrobials.
A TEV can be used for the antimicrobial itself, transferred to a different product or even sold to another marketing authorisation holder. The requirements for the grant and use of a TEV are detailed, reflecting a concern that incentives should be carefully focused and not applied to blockbuster products.
Repurposed medicines
A novel standalone period of four years of data protection will be available for repurposed medicinal products, where a new indication is approved for an existing active ingredient.
The revised data and market protection framework, together with the additional new protections for antimicrobials and repurposed medicines, offer a tailored set of incentives for investment in the development of medicines.
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