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Benefits and bottlenecks for early marketing authorisation of new medicines

Publication date: 28 October 2016
Modificationdate: 08 November 2016

Patients are asking increasingly often for quicker access to new, innovative medicines. This requires a more effective use of flexible marketing authorisation procedures. Manufacturers, marketing authorisation and reimbursement authorities, patients and healthcare providers are working together to explore what is required to achieve this. RIVM investigated what benefits and potential hurdles might influence this new marketing authorisation concept.

Adaptive pathways

The demand for quicker access to new, innovative medicinal products that are not yet licensed or for which reimbursement via the health insurance system is not yet available is increasing. Therefore the European Medicines Agency (EMA) is looking whether early consultation between manufacturers, marketing authorisation and reimbursement authorities, patients and healthcare providers can contribute to using existing flexible marketing authorisation procedures more effectively. This way of looking at existing procedures in a different manner is called ‘adaptive pathways’. For example, it is intended that the procedures for marketing authorisation and reimbursement, which currently take place one after the other, should run in parallel as far as possible. Furthermore, patients and healthcare providers will be involved structurally and at an early stage in the processes of clinical study design, the development pathway, marketing authorisation and reimbursement. 

Benefits

Research by RIVM shows that the parties that would be involved with or affected by adaptive pathways in the Dutch situation do see added value in it. They are positive about the early collaboration between the Dutch Medicines Evaluation Board, patients, healthcare providers and reimbursement authorities. They expect that adaptive pathways will enable medicines to better match patients’ demands and perhaps do so more cost-effectively. What this means for the reimbursement of these kinds of products needs to be studied more thoroughly.

Bottlenecks

At the same time, the parties interviewed point out that greater investment is required to monitor the safety and quality of medicinal products after they are licensed. This can, for instance, be done through extended or adapted patient records and monitoring systems. In addition, they indicate that bridging the time gap between international marketing authorisation and inclusion in the national reimbursement system is a very complex issue. This would require extensive coordination and cooperation at international level. Furthermore, they think clear agreements are necessary to decide what to do when early accepted medicines do not add the expected value. There should be a discussion whether these medicines can be withdrawn from the market.

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