Published 19th May 2023
The long awaited EU Pharmaceutical Legislation Proposal has been released. This reform of the legislation aims to make medicines more “available”, “accessible” and “affordable” alongside supporting innovation.
On the 26th April 2023 the European Commission (EC) published the major draft proposal for the reform of the pharmaceutical legislation. This was presented as the new Directive to replace the existing Directive 2001/83/EC as amended covering the aspects of medicines authorisations, monitoring, labelling and regulatory protection alongside a new Regulation which lays out the requirements for medicines governed by the EMA, security and supply of medicines. Finally, a new publication issued by the European Council to cover the recommendations for the initiatives to tackle antimicrobial resistance.
The draft has recognised the need to incentivise the re-purposing of medicines with a 4-year data protection period for existing medicines developed for new therapeutic indications. However, this is balanced with reducing the standard data protection period from 8 to 6 years with the additional 2 years market exclusivity based on specific conditions of market launch meaning a potential regulatory protection of 12 years. This could add complexity to calculation of data protection period for cross referencing products in the future.
Wit the global agenda of climate change targets there is a need to regulate medicines to minimise the use of hazardous materials, reduce pharmaceutical waste and consider incentives of more sustainable packaging options.
A key change in the directive is the option for member states to “opt in” to a procedure on public health grounds meaning applicants cannot strategically avoid submissions to particular member states. Member states can become more empowered by the directive allowing the reference member state to terminate poor quality applications which cannot be resolved within a set time period. With the MRP there will be a minimum time period of 12 months before a new concerned member state can be included unless there is an expressed interest by the concerned member state.
Within the new regulation proposals which will merge the aspects of the orphan and paediatric Regulations alongside the existing regulation for governance of the EMA medicines and supply
The proposal introduces a reduction of the assessment times form 210 days to 180 days. These shorter assessment times are also captured for the decentralised procedures under the new Directive. However, the accelerated route will remain at 150-day assessment time reducing the advantages of the fast-track route. There will be a reduction in the time for the European Commission Approval from 67 days to 46 days.
Market exclusivity as standard reduced to 9 years with 10 years on high unmet need only and reduced to 5 years for bibliographic application.
The evaluation has meant that no changes in the protection period for paediatric indications and the 6-month supplementary protection certificate extension will remain. However, to reduce the administrative burden the proposed changes include a simplification of the process with the agreement to create the development plan at precise stages during the development to avoid the requirement for modifications of an initial plan.
In addition, there is a plan to increase the obligation to study medicines in children based on the molecular mode of action for different targets not originally designed for adults.
The new regulation proposes the concept of a regulatory sandbox for innovative developments where there are challenges in within the scope of current regulations.
Improving the management of supply of critical medicines include obligations to notify on permanently ceasing supply at least 12 months prior to last planned supply and 6 months for temporary suspension of supply. Shortage Prevention Plans will be required by all marketing authorisation holders
Finally, the European Council have proposed recommendations for Antimicrobial Resistance. The councils recommendations present an environment of a one health approach. It includes improving the responsible use of the antimicrobials by improving the surveillance with setting targets with reduction in antibiotic use by 20% and reducing infection rates of key antibiotic resistant bacteria alongside the reduction in use in farming. Alongside promoting development of new antimicrobials through a voucher incentive scheme providing for an additional year data protection for priority antimicrobials. Nevertheless, the targets will not be legally binding on the member states
The exact timings for the review, adaption and implementation of the proposed pharmaceutical legislation is unclear. It will need to be discussed by the European Parliament and Council. Following the finalisation, it would be a further 18 months after entry into force and to consider another 18 months before each member state would transpose into national legislation