EU Pharmaceutical Legislation Reform to Enable Quicker Access and Foster Innovation

In April 2023, the EU commission’s proposal to revise the pharmaceutical legislation consisted of two legislative proposals: a new directive and a new regulation, both aimed at simplifying the previous pharmaceutical legislation.

The main objectives of the revision of the EU pharmaceutical legislation included:

The new directive and the regulation listed out the specific rules and requirements to authorise medicines at the EU and the national level, to label, to protect the regulatory data as well as to coordinate management of critical shortages and security of supply of critical medicines.

To enable faster authorisation of new medicines and reduce the current average of around 400 days between submission and market authorisation of new medicines, the new regulatory framework suggested the following changes¹:

Further, to promote development of innovative medicines, following simplified authorisation procedures have been proposed:

a. the EMA to provide early scientific advice to improve the quality of applications

b. tailored scientific support to SMEs

1. rolling reviews
2. temporary emergency marketing authorisations for health emergencies
3. the EMA to provide advice to innovators on their product even years before they actually apply for a marketing authorisation
4. regulatory ‘sandboxes’ to allow testing new regulatory approaches for novel therapies under real world conditions
5. repurposing of medicines to be incentivized
6. medicines delivering on high unmet medical needs to be incentivized
7. minimum period of regulatory protection of 8 years (6 years of data protection + 2 years of market protection) to be offered to companies marketing innovative medicines. The period of 8 years can be further extended as follows:
   1. 6+2+2 = 10 years if the companies launch the medicine in all member states
   2. 6+2+6 months = 8.5 years if the medicine addresses an unmet medical need
   3. 6+2+6 months = 8.5 years if comparative clinical trials are conducted
   4. 6+2+1 year = 9 years if the medicine can treat other diseases too
   5. If the medicine covers all the above criteria, overall regulatory protection would be for 6+2+2+0.5+0.5+1 = 12 years
8. minimum period of market exclusivity for medicines for rare diseases to be 9 years and can be extended to a maximum of 13 years

With such measures in place, pharmaceutical companies would be persuaded to bring innovative medicines to the market and launch it in all member states of the EU.

References:

1. https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_1844