Most of the MRP/DCP products tested in 2015 were generic drugs
The General European OMCL Network (GEON) successfully met increasing market demand in 2015 for independently testing the quality of medicines, blood-derived medicinal products and vaccines in Europe.
Reviewing the various work programmes of the Official Medicines Control Laboratories (OMCL) Network, this year’s Annual Meeting heard that in 2015, the Official Control Authority Batch Release (OCABR) Network carried out 12% more protocol reviews and testing of final lots of blood-derived medicinal products under the OCABR system, compared with the previous year.
In 2015, the OCABR Network dealt with a combined total of nearly 12,000 final lots proposed for OCABR for human blood-derived medicinal products and vaccines, independently confirming their quality through experimental testing and protocol review before they reached patients.
Representatives of 61 OMCLs from 38 countries (including Canada, Israel and Singapore) also heard that more than 1,000 product-testing projects were added to the OMCL Network’s 2015 work programme for the market surveillance of medicinal products authorised in the European Economic Area (EEA) through the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) system.
The 996 test reports entered in the OMCL database in 2015 (slightly more than the 987 entered in 2014) represent a 23% increase over 2013, in the context of an average 10% increase each year since 2011.
Most of the MRP/DCP products tested in 2015 were generic drugs, reflecting their increasingly important role in healthcare systems, especially in those areas where safe, high-quality, cost-competitive medicines are a real necessity for patients. It is reported that 55% of all dispensed medicines in Europe are generics, and savings relative to branded products are estimated to be around 20% in the first year of generic entry in the market, rising to 25% after two years.
The sharing of workloads, resources and expertise among the OMCL Network members makes it possible to avoid duplication of work and gives them access to the latest technologies and selective methods of analyses. This and the mutual recognition of test results mean that member states can ensure an adequate market surveillance of authorised medicinal products, while reducing costs and ensuring the quality of medicines on the market in the interests of public health.
Based on these principles, the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, which co-ordinates the GEON, launched a collaborative database system for MRP/DCP products in July 2007 to ensure communication between the participating OMCLs. As of December 2015, this database held some 7,300 testing records, with contributions from 34 OMCLs.
In practice, work-sharing for market surveillance across the OMCL Network produces a nine-fold benefit: from 2002 to 2015, a participating member state testing one product received test results for an average of nine products generated by other member states, enabling each OMCL to achieve a far higher coverage of products than it would be capable of doing on its own.
The 2016 GEON Annual Meeting held in Paris provided an opportunity for OMCLs to further enhance this work; it was a forum for exchanging the latest technical information and discussing strategies for increasing the value of the GEON’s contribution to public health: how to improve communication, optimise work-sharing and maintain coverage and depth of competence whilst remaining flexible and reactive in response to increasing demand in an evolving pharmaceutical world.