Regulatory Toolbox for Medicines and Combined Device Developers

We will be releasing this information in 3 parts – so keep an eye out for Part 2 next week.

Larissa Gould reports from the EMA in Canary Wharf on the latest developments. Presentations were from key regulatory personnel and industry professionals who met to discuss the resources available at the EMA.

The EMA provided SME companies with the opportunity to attend an information day. The ‘meet the EMA’ session highlighted the range of services provided by the EMA and allowed direct discussion with relevant personnel. An awareness session provided a brief summary of the new EMA portal named IRIS. This is currently mandatory for all orphan submissions and may be rolled out in the forthcoming years for all EMA regulatory submissions. The day also importantly provided for networking during the session breaks. The agenda and presentations are available on the EMA website.

SME Presentation from Sonia Ribeiro

Sessions opened with a detailed presentations from Sonia Ribeiro on the definitions and timing for data exclusivity and market protection, showing that after 8 years data exclusivity for a particular Marketing Authorisation, the EMA could receive generic applications referencing that MA. Market protection would continue for another 2 years, where generics would not be able to be launched onto the market even if a Marketing Authorisation (MA) was issued. This market protection could be extended by a further year (to 3 years in total), if a new indication approved within the first 8 years brought significant clinical benefit compared to existing therapies.

Global Marketing Authorisation

The concept of a Global Marketing Authorisation for one active substance was explained, where all salts, esters, ethers, isomers and pharmaceutical forms of a substance are not further protected from regulatory submissions referencing the first MA (e.g. generics) unless there are significant differences in safety and/or efficacy.  Additional 1 year data exclusivity also applies to products that have changed classification following the generation of significant clinical or pre-clinical data. The incentives for orphan medicines were presented, including the 10 year market exclusivity protection from similar medicines in the same indication, plus a further 2 years for completion of the PIP. This 10 year market exclusivity for orphan products can be reduced to 6 years post-authorisation, if orphan designation criteria are no longer met.

Paediatric Medicine Regulation

The paediatric medicine regulation provides the obligation to study drugs in children under an agreed Paediatric Investigation Plan (PIP), unless a waiver is applicable for a particular medicine.  The PIP is necessary for the validation of applications for new products and new indications, as well as PUMA applications of off-patent medicines. The rewards are 6 months extension of the Supplementary patent Certificate for a new medicine or new indication of an authorized medicine on patent. As already mentioned, the PIP rewards for orphan medicines allow for 2 additional years of market exclusivity. The PIP rewards for a PUMA are 8+2 years data protection.

SME Incentives & Support

There are a range of incentives and support for SMEs developing new medicines or indications in difficult areas, such as rare diseases or where obtaining a full clinical data package is challenging. The European Commission have published a study on the ‘Economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe’. You can read more details here. Key findings include the fact that average development time for medicines is increasing (previously 10 years and now 15 years) with an associated decrease in effective protection period (previously 15 years and now 13 years). However, in 51% of cases the sample patent was last to expire and there is a positive relationship between effective protection and level of pharma R&D.

This is the first instalment of this fascinating report – two more to follow. Remember S-cubed is able to act on your behalf post-Brexit. If you are looking for representation in the EU, get in contact via our Regulatory Affairs Page.