Organisational changes critical to EMA's sustainability, says new report
This article was originally published in SRA
While the European Medicines Agency has proven effective in protecting human and animal health in the European region, the whole medicines authorisation system "is progressively attaining its maximum capacity", says a new report published by the European Commission1,2. Thus, there is an urgent need for the agency to appropriately alter its organisation to ensure its sustainability in the face of novel challenges.
The report contains an evaluation of the EMA's performance conducted between January and December 2009 by consultancy Ernst & Young at the commission's request. The publication of the report fulfils the commission's legal obligation to conduct an evaluation of the EMA by 2009-10 under Regulation (EC) No 726/2004, which established the agency3.
The findings and recommendations in the 236-page report focus on seven key areas relating to: the organisation of EMA committees; the involvement of national competent authorities in the agency’s work; the role of the EMA Secretariat; procedures; communication; industry fees; telematics; and future challenges.
While the EMA has adapted successfully to the European Union’s enlargement (in terms of involving new national competent authorities) and to major scientific evaluations such as the emergence of advanced therapies, the report points out that the agency is finding it difficult to cope with this increased workload.
In particular, the EMA’s main scientific committees, such as the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP), it says, “are overwhelmed with work and their agendas could hardly be extended”.
While the report regards the Committee for Orphan Medicinal Products (COMP) as a success, its sustainability, it says, may be put at stake both because the system may not appropriately compensate national competent authorities for their involvement, and because of potential evolutions, such as personalised medicine, which could end up significantly complicating the orphan status designation procedures.
The report suggests that all committees within the EMA should be classified into two types: “opinion-making” (eg CHMP, CVMP and COMP), which deliver opinions that are directly followed by a commission decision; and “pre-committees” (eg the Committee on Advanced Therapies or CAT), which prepare the scientific opinion that will be finally made by the CHMP or the CVMP.
Such a differentiation, if adopted, the report says, will make the resulting roles and responsibilities of each committee more obvious and consistent for all types of stakeholders.
PDCO v CHMP
The report notes that from an operational and governance point of view some concerns have been expressed over the status of the Paediatrics Committee (PDCO) vis-a-vis the CHMP.
While the PDCO is currently an opinion-making body focused on a very specific field (early paediatric development plans), its opinion is not followed by a commission decision. The PDCO, the report suggests, should evolve towards a pre-committee model to reinforce the consistency of the whole system.
The report also makes suggestions to decrease the workload of opinion-making committees. This, it says, can be achieved by creating additional temporary targeted pre-committees for referrals and for generic products. Under such an arrangement, the assessment work would be the responsibility of the pre-committees, while the outcomes of those assessments would be validated by the CHMP or the CVMP.
Scientific advice procedure improvements
Although pharmaceutical companies consider the EMA’s scientific advice to be very useful and of good value, the report notes that the industry often regrets that the process is “too complicated” and thus takes too much time, especially when compared with the scientific advice offered at the national level in the US.
All stakeholders contacted by Ernst & Young while preparing the report agreed that the EMA’s scientific advice procedure is more formal than that of other national competent authorities. In particular, they noted that the EMA’s Scientific Advice Working Party (SAWP) only provides written responses.
“While this formalisation is understood to be a consequence of having 30 countries present at the table, some observers nonetheless believe that it may hinder a more open discussion between the applicant and its advisors,” the report says, adding that at the national level, some national competent authorities avoid giving written responses and rather favour face-to-face meetings.
The report states that the EMA’s scientific advice procedure can be improved by, among other things, streamlining the pre-submission process. Also, the EMA could consider “facilitating communication with the industry, maybe by making an entry point more available throughout the procedure (and not providing only written responses).”
References
1. European Commission, Latest News on Pharmaceuticals, 12 April 2010, http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/new_en.htm
2. European Commission, Evaluation of the European Medicines Agency, Final Report (January 2010), Posted online 12 April 2010, http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/pharmacos/news/emea_final_report_vfrev2.pdf
3. Kermani F, Evaluating the European Medicines Agency, The Regulatory Affairs Journal – Pharma, 2009, 20(4), 220