MEB-ZIN Parallel Procedure pilot: Accelerating Access for Patients
The MEB-ZIN Parallel Procedure pilot was launched in 2019 in the Netherlands to investigate the feasibility to perform the registration and reimbursement process in parallel to shorten the time to access of new drugs.
The Netherlands is one of the fastest countries to grant access to new medicines with a mean time of access of 213 days shown by the European Federation of Pharmaceutical Industries and Associations (EFPIA) patients WAIT indicator in 2020. To optimize the time of access further, the Medicines Evaluation Board (MEB / CBG) and the National Health Care Institute (ZIN) have started a pilot “Parallel Procedure”. This pilot aims to further speed up access to medicines and develop a parallel registration and reimbursement process by conducting their assessments simultaneously.
In the reimbursement standard procedure, companies can only submit their reimbursement dossiers once the European Public Assessment Report (EPAR) has been published by the European Medicines Agency. In the pilot, dossiers can be submitted just after the CHMP has completed its second assessment (at day 180 of the authorization period), as long as no major objection has been raised that could impact decision-making downstream. ZIN will start the assessment. When the CHMP has issued a positive opinion, ZIN will then conclude the assessment.
The parallel procedure demands earlier timelines for the applicant to finalize the reimbursement dossier. For several companies, this was not feasible and therefore they could not join the pilot. The parallel procedure involves intensive contact between the MEB, ZIN, and the applicant which was more labour-intensive. Thus far, the parallel procedure have been successfully finalized for three new drugs: oral semaglutide, liposomal amikacine, roxadustat. For these drugs, the parallel procedure reduced the time of the reimbursement process with an average of three months. The assessment of two other new drugs is ongoing.
By reducing the time to access with three months, the pilot has proven to be feasible and successful. More products in different therapy areas will be piloted to further fine-tune and standardize the parallel procedure and to strengthen the collaboration and information exchange between ZIN and MEB.
Outcomes of the 2nd European Stakeholder Workshop of STARS in November 2021
Towards a Common Strategy to Empower Academia in Regulatory Awareness and Knowledge
STARS stands for Strengthening Training of Academia in Regulatory Science. The STARS consortium consists of the majority of the national competent (health) authorities (NCAs) in Europe and the European Medicines Agency. This coordination and support action is funded by the European Commission (Horizon 2020) and the main objectives are to strengthen regulatory knowledge in academia by reaching clinical scientists during professional training and qualification, as well as by improving the dialogue of academic drug developers with regulatory authorities.
The 2nd European Stakeholder Workshop entitled "Towards a Common Strategy to Empower Academia in Regulatory Awareness and Knowledge" focused on improvement strategies for the regulatory support to academia and bridging the translational gap of academic-driven health research. During this event, where 61 stakeholder representatives participated, an update about the developments in the STARS project including the two pilots was provided. Particularly, attention was given to the draft of the STARS Common Strategy.
The STARS Common Strategy was developed by the STARS consortium and is aimed to serve as a roadmap to strengthening regulatory science and gives recommendations to improve the regulatory knowledge, awareness and skills of academia across Europe. It is addressed to the European Commission, stakeholders across Europe and the member states and regions, including academia, NCAs, research and health ministries, policy, funders, industry, payers and the public. At the time of the workshop, 21 draft recommendations of the Common Strategy, which were developed based on the outcome of several STARS surveys, all STARS activities as well as the stakeholder’s input from the first STARS workshop, were discussed. The stakeholders agreed that the most important aspects were considered in the current draft and only a few aspects were missing, such as, for example use of organisations like funders, publishers and medical societies to promote regulatory science in academia, to strengthen innovation offices at NCAs to be able to provide timely support to academia.
In addition, the STARS Consortium received valuable input and comments on how to further specify the recommendations. All these contributions will be incorporated into the final version of the STARS Common Strategy, which will be published on the STARS website in May 2022.
The Strategic Document and respective recommendations aim to support sustainability of the regulatory support to academia beyond the STARS project.
For more information, see the STARS-website.
