The EMA under pressure
The EMA has received criticism from several MEPs for its perceived lack of action (9–11). In 2011, the EMA responded directly
to the media, arguing that the globalisation of clinical trials was presenting it with a huge regulatory challenge that it
was ill equipped to deal with. The EMA expressed the need for more resources and improved cooperation from the pharmaceutical
industry to respond to the matters raised in the European Parliament, pointing out that all clinical trials, regardless of
their nature, are required to meet internationally agreed ethical and data quality standards or their equivalent.
However, critics of the EMA are not satisfied. Wemos has argued that the regulatory agency is not being proactive and should
be closely questioning companies about their conduct before granting regulatory approval for products (10, 11). In March 2012,
MEPs on the Environment, Public Health and Food Safety Committee renewed demands for answers from the EMA regarding allegations
of informed consent, inadequate investigation of deaths, conflicts of interest and other breaches for several trials conducted
in India (11). The EMA acknowledged that there were still problems and promised to increase transparency to show how it was
trying to enforce standards, but Dr Fergus Sweeney, the EMA's head of inspections, appeared to reject the demands of certain
MEPs to refuse market authorisation for any ethical breaches (11).
Perhaps as a response to this criticism, the EMA has been keen to highlight the recent work it has been doing to ensure a
robust global framework for the conduct and oversight of clinical trials. In April this year, the EMA's Working Group on Clinical
Trials conducted outside of the EU and European Economic Area published a final reflection paper on the issue (13). The paper
entered into force on 1 May 2012, with the aim of making sure that all standards are formally enforced, regardless of where
in the world clinical trials are conducted.
One of the key steps that the EMA believes will enable it to enforce standards is better international cooperation. The agency
recommended that a common international approach to the oversight of clinical trials be adopted, particularly with respect
to countries where ethical and regulatory systems are not fully developed. A clear difficulty identified in the paper is for
countries where EU regulators have limited existing formal contacts or experience in the local conduct of clinical trials
As a starting point to prioritise its international focus, the EMA has collected data on the numerical distribution of patients
participating in pivotal trials included in regulatory applications submitted to the Agency (10). In Africa, it identified
South Africa as the major contributing country, whereas in Asia it was India, the Philippines, Thailand and China. In Latin
America, a number of countries were highlighted including Brazil, Argentina, Mexico, Costa Rica and Peru. However, the EMA's
data can only account for centrally authorised products, and so it is continuing to collect information at a Member State
level and from international sources, such as the World Health Organisation (WHO) to create up a better picture of the situation.
From the available and emerging information, the EMA has proposed that high level "mapping" of information should be established
in cooperation with individual European regulatory authorities and other international organisations (10). The exercise will
effectively grade countries on the basis of the strengths and weaknesses of their regulatory systems, and whether the EMA
can offer any assistance in the field of clinical trial regulation.
There will also be discussion on opportunities for collaboration based on the needs identified in the countries included in
the priority list. The EMA already runs international collaborative projects in other areas, such as GMP inspections (14).
The success of these programme can serve as a suitable framework to build collaboration for the purposes of enforcing clinical
The EMA has also noted that there are existing collaborative programmes in other regulatory areas, which may feature aspects
of clinical trial regulation. Therefore, the agency is keen to look for synergies with other initiatives and to avoid the
duplication of effort. However, the EMA has acknowledged that the results of some of the initiatives that have been conducted
to date have not always been well documented, so there may be gaps in knowledge to overcome if its proposed international
work is to complement existing programmes (13). There are also some basic, practical issues that the EMA must deal with such
as developing a contact list of representatives of the foreign organisations it wants to deal with and determining appropriate
For the EMA to become a stronger force for the enforcement of clinical trial regulations, it will also need greater resources
and training. The final reflection paper mentions that training will involve courses, workshops and support for the preparation
of guidelines and SOPs (10). However, it is not clear where the EMA will be getting additional resources from to cope with
the growth of its activities or how they will be financed.