The European Commission (EC) has adopted a proposal for a new Directive and a new Regulation which will revise and replace the existing pharmaceutical legislation, and amount to the largest regulatory reform in the EU in over 20 years. The Directive and Regulation have been submitted to the European Parliament and the Council of the EU for discussion. The EC confirmed that discussions will start as soon as possible, however it cannot predict the timing for adoption. Both the Parliament and Council will need to approve the reforms.
The regulatory reforms aim at increasing patient access to affordable medicines and improving the security of supply. EC Vice-President Margaritis Schinas has described the changes as “enormous”.
Key measures include:
- A 2 year reduction of the baseline data protection period in order to encourage early market access of generics and biosimilars. However, additional periods of data protection may be available when certain conditions, potentially extending the period of regulatory protection beyond those currently available.
- Companies marketing innovative medicines will have a minimum period of regulatory protection of 8 years, which includes 6 years of data protection and 2 years of market protection. However companies may benefit from additional periods of protection (total period up to 12 years, compared 11 years today). These additional periods of protection can be obtained if the medicine is launched in all Member States (+2 years), if the medicine addresses an unmet medical need (+6 months), or if comparative clinical trials are conducted (+6 months). A further year of data protection can be granted if the medicine can treat other disease(s) too. The 2 year protection based on launch in all Member States is expected to increase access by 15%.
- For rare disease medicines the standard market exclusivity will be set at 9 years. Companies may benefit from additional periods of market exclusivity if they launch in all Member States (+ 1 year), address a high unmet medical need (+1 year), or develop new therapeutic indications for an already authorised orphan medicine (up to 2 extra years). The total regulatory production periods can add to 13 years (today the maximum is 10 years).
- Broader scope of the ‘Bolar exemption’: biosimilars will not need risk management plans as the originator will already have one.
- An incentive for repurposing
- Faster authorisation of new medicines:
- The EMA will have 180 days instead of 210 to assess new medicines
- If medicines are of major public health interest, the EMA will only take 150 days
- The EC will have 46 days instead of 67 for authorisation
- Regulatory ‘sandboxes’ to test new regulatory approaches for novel therapies under real world conditions.
- The ability for governments to suspend data and market protection when a compulsory licence has been issued to tackle a public health emergency.