The European Medicines Agency (EMA)’s two main opinion-making committees are “overwhelmed with work,” and the whole system is fast reaching maximum capacity, an evaluation of the Agency has concluded.

The agendas of the EMA’s Committee for Medicinal Products for Human Use (CHMP) and its counterpart for veterinary drugs (CVMP) “could hardly be extended,” says the report, and it suggests that, to overcome these workload issues, two dedicated committees need to be set up, one to deal with referrals and the other with generics.

The report is produced by Ernst & Young, which conducted a year-long evaluation of the Agency on behalf of the European Commission’s Directorate-General for Enterprise and Industry. Its findings are generally positive, concluding that the system provides “complete, clear and highly-valued opinions within tight regulatory deadlines and allows the contribution of the best available experts in Europe, while ensuring the impartiality of their assessments.”

Moreover, it finds that the system’s effectiveness has been maintained despite its growing complexity, with the attractiveness of the centralised procedure, EU enlargement and new regulations having increased the Agency’s workload and enlarged the scope of its responsibilities over the last 10 years. The EMA Secretariat contributes strongly to the system’s effectiveness and has proved to be a learning organisation, with operational efficiency having improved during 2000-2008. The Agency’s core activities doubled over this period and its budget has followed the same trend, but the increase in the workforce has not; “however, the quality of the work has been maintained,” says Ernst & Young.

Another significant EMA panel, the Committee for Orphan Medicinal Products (COMP) is generally considered to have been a success, but its sustainability could be at stake, the report warns. This is because national competent authorities (NCAs) may not be receiving appropriate compensation for their involvement, and also because developments such as personalised medicine “could end up significantly complicating the orphan status designation procedures.”

While stakeholders generally recognise that the Agency is continually striving to improve its timelines and procedures, companies and NCAs have both noted their regret at the “high level of formalism” involved with the provision of scientific advice which, in some cases, may hinder discussions, they claim, although the report comments that this formalism may also prove to be a guarantee of independency and transparency.

Moreover, drugmakers generally consider the fees which they pay to the Agency to be fair and appropriate to the services provided, except in the case of scientific advice, which they often consider to be too expensive. Nevertheless, they have welcomed the recent introduction of a new scientific advice procedure, as this has helped reduce delays and simplify the process which had proved a “major hindrance” for them.

Interviews conducted for the evaluation also reveal that many stakeholders regret the fact that medicines distribution falls outside the Agency’s areas of responsibility, given that many centrally-authorised products are available in only a limited number of member states. The report suggests that, by monitoring the data which the Agency already receives from industry under the “sunset clause” - the requirement for centrally-authorised products to be placed on the EU market within three years of the authorisation being granted - it may be able to identify the system’s weaknesses.

It adds that this issue highlights an important challenge for the EU authorisation system in the coming years, not only regarding the follow-up of distribution as a first step but also in taking action to broaden the distribution of authorised medicines to optimise the system’s impact on public health. This challenge may require political action at both EU and member-state level, it suggests.