EMEA to set out road map for next five years

The European Medicines Agency's strategy for the next five years will focus on three core areas: addressing public health needs; facilitating access to medicines; and optimising the use of medicines. The final draft of the Road Map to 2015 will be presented to the agency's management board on 10 December, with a view to starting the public consultation period in January 2010.

The key elements of the Road Map were divulged at the joint meeting between TOPRA and the EMEA in London on 1 December by Noel Wathion, head of unit Patient Health Protection at the EMEA. It is a continuation of the Road Map to 2010 project that was drawn up in 2004 and builds on current achievements while also taking account of changing business drivers.

The top priority over the next five years will be the need for efficiency in the Agency's operations. "We have to recognise that the roles and responsibilities of the EMEA have further expanded since 2005. We have new legislation in the fields of advanced therapies and paediatrics and there will be new legislation in three fields as part of the pharma package," Wathion said.

"We also have to recognise that the tasks of the agency have become much more complex. We have six scientific committees and will have another one within two years; we also have 35 working parties and other scientific forums to which we have to provide scienfitic support.

"Efficiency will be even more key because we have to bear in mind that resources are limited. The focus will now more be on how to increase the quality of the outcome of the work performed by the EMEA and its various committees."

In terms of addressing public health needs, the focus will be on gaps in medicine development, with incentives for unmet medical needs/rare and neglected diseases, such as through an accelerated assessment scheme. There will also be initiatives to address the lack of development of antibiotics and the potential threat from the development of antimicrobial resistance; and to meet the challenge of demographic changes - primarily population ageing.

Another focus will be on new and emerging science, such as personalised medicine, nanotechnologies, regenerative medicine and synthetic biology. There will be a need to consider the appropriateness of the current legal/regulatory framework and how to best translate the new science into regulatory requirements, ethical and environmental considerations.

The most obvious threat to public health at present is the pandemic influenza situation, and Wathio said the EMEA is learning from this particular exercise. "We are confronted with public health threats, all of which have three issues in common: the complexity of the issue, the global dimensions of it and the need to find a quick solution," he told the delegates. "What we are proposing, taking into account the experience we are building up, is to revise the preparedness mechanisms and to prepare each time a Lessons Learnt.."

When it comes to facilitating access to medicines, EMEA's focus will be on the development process, notably early assessment and continuing dialogue through, for example, optimisation of the Scientific Advice process and strengthening the involvement of stakeholders in guideline development, by involving patient organisations and academia at a very early stage.

"A very important aspect is that nowadays we are seeing quite a lot of medicines that don't make it to the end, and a lot of information available is lost," said Wathion. "We would like to explore what kind of incentives we could give to sponsors of failed drug development to make that knowledge available to the scientific community."

A lot of emphasis will also be placed on the benefit/risk assessment and communication and here the EMEA would like to move directly into including more quantitative elements and patients" values in benefit/risk considerations. "For instance, we will be going to the board with a document that has been widely debated at the level of our patient groups on how patient organisations should be further involved in EMEA activities, including the scientific review process," Wathion explained.

The theme of benefit/risk management rather than just a risk management plan is also a key feature of the EMEA's initiatives to optimise the use of medicines. It is important to streamline the collection of post authorisation data on both benefits and risks and include it in the current Scientific Advice framework, something that is not happening at this particular moment, according to Wathion. At the beginning of 2010 the EMEA will announce the implementation of ENCePP (European Network of Centres of Pharmacovigilance and Pharmacoepidemiology). "We believe this will be an important tool for the collection of post-authorisation data," he said.

In the field of patient safety the Agency will undertake a revision of the risk minimisation toolbox. It will also look to make to further progress on the European Risk Management Strategy (ERMS) in terms of new data sources for monitoring of medicines and capacity building for post-authorisation monitoring

It will also be looking at the very important impact on the regulators and the pharma industry of the introduction of the international standards and terminologies that are currently being developed in co-operation with international partners such as the FDA in the US and the MHLW in Japan.

Wathion stressed that the road map is not a standalone document; it will be complemented by an implementation plan entitled From Vision to Reality.

"This is a longer term plan - not everything will be done within the first year," he said. "We also have to bear in mind that certain issues are already ongoing, so we are not starting from scratch. This will be a gradual implementation of the Agency's vision over the next five years."