The European Medicines Agency’s new roadmap

The EMA’s executive director Thomas Loenngren talks to Andrew Tolve about what to expect from the organization’s new regulatory priorities.

The European Medicines Agency has drafted a new roadmap to govern its strategy for the next five years. The document is out for review by key stakeholders, including pharmaceutical companies, patient organizations, healthcare professionals, and regulatory partners. The general public will be able to view the new roadmap on EMA’s website and voice comments there as well.

“The purpose of this new roadmap is to reassess how we can optimize the whole chain from early drug development to patient use,” says EMA’s executive director Thomas Loenngren. “We’re trying to focus on issues where we have an important role in this cycle and then optimize that role from a public health point of view.”

EMA was the first regulatory agency to draft a roadmap in 2004, an initiative that resulted in the MA Roadmap 2010, which, for the past five years, has communicated the agency’s priorities and steered its year-to-year objectives. Loenngren says he expects this new roadmap to do the same until 2015, when European drug policy and legislation will be revised. After the comment period is over, the agency will draft a more concrete document, which EMA’s management board likely will adopt in June.

All of this comes at an important time for the agency and the pharmaceutical industry. The healthcare environment has transformed in the past five years, and so has EMA. Just this year, the association changed its acronym from EMEA to EMA and honed its focus on science, medicine, and health.

Public health needs

With this in mind, the new roadmap is focused on three specific strategy areas, the first being public health needs. “Under this heading, we are looking into gaps in medicine development,” says Loenngren, “and how we want to stimulate drug development in order to fill these gaps. There are a lot of neglected diseases, for example, in developing countries where we have special regulatory medicine in Europe for helping or give scientific opinions, such as HIV and tuberculosis.” Gaps in medicines for diseases afflicting the elderly (like Alzheimer’s and Parkinson’s) are another example.

Also under this first heading is a concentration on new and emergent sciences that can be embraced to develop new medicines. “Certainly the area of personalized medicine is high on our agenda,” says Loenngren, “and how we could facilitate biomarkers and diagnostic tools in order to stratify medicines in drug treatment. That could save a lot of cost in drug development and could optimize treatment, both for inclusion or exclusion of patients, but also to shorten the drug development process.”

Access to medicines

The second focus of the roadmap is how EMA can facilitate access to medicine and ameliorate the high attrition rate in drug development. “We are asking ourselves the question, ‘What can we do as regulators to improve drug development?’ says Loenngren. “So we’re looking at how we can guide the companies and the industry for early drug development. We think we could help in order to stop candidates at an early stage before they cost so much money, if it’s clear they will fail.” EMA is considering ramping up the amount of early advice they give to companies as well as offering other solutions, like a new set of guidelines or better benefit risk studies.

The final strategy area is optimizing the safe use of medicine, which entails improving the reporting of incidents (spontaneous reporting is a particular focus here), improving the communication of health risks, and improving the assessment of decisions passed down by EMA. “This is one of the areas that we would like to do more in,” says Loenngren. “We need to analyze the decisions we are making as a regulatory agency. We make a lot of decisions, but the question is, do these decisions have an impact on how drugs are used? So we’re considering doing more outcome studies to see how drugs are being used in reality. Are warnings picked up by healthcare professionals and patients? We really want to learn how we can make our activities more effective.”

Global focus

Loenngren adds that, beyond these three core strategy areas, hovers a broader focus on globalization. Ten years ago, most of the medicines EMA dealt with were researched in Europe and the United States and manufactured there too. Now many are manufactured in other territories, predominantly China and India, where the clinical trials for many of these drugs are conducted as well.

“That changes the roll of us as regulators,” says Loenngren. “[It] means we need to work together, not only between the US FDA and EMA but also between other regulators in the world. The pharmaceutical market has become a big global supermarket of pharmaceutical businesses, which calls for more international collaboration among agencies.”

EMA already has taken steps to embrace a more global mindset. A member of the US FDA, for instance, now sits in a office down the hall from Loenngren, as does a member from the Japanese regulatory authority. But Loenngren says he wants the agency to continue to do more.

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