Pharm Exec: Your decade as Executive Director might best be characterized as an era of institution building. I see it as transforming a basic premise—that European integration required a more coordinated approach to certifying drug safety and efficacy—into specific processes, policies, and platforms that today are accepted by key stakeholders. Has the transition you've achieved helped preserve Europe's position as the world's largest market for medicines? What and where is the benefit?

Thomas Lonngren: The Agency is a relative newcomer to medicines regulation, having begun operations only in January 1995—some seven decades after the creation of the US FDA in 1930. So we have had a short learning curve. We are also an institution unique to Europe, with a mandate to coordinate scientific assets from the 27 EU member states and three European Economic Area (EEA) countries for the evaluation, supervision, and pharmacovigilance of medicinal products for human and veterinary use. What this means in practice is that we are an institution built around partnership, with our principal contacts being the national registration authorities with whom we administer a single, centralized EU-wide marketing authorization for new medicines granted through the European Commission. This task is a delicate one, as we must balance the need for process coordination with a complex web of policy interactions. Partnering well requires political wisdom; the metric for success is being accountable to the European institutions and the member states through good science, strong evidence, independent professional judgment, and—most important—a high level of transparency and communication.

The "incentive to consult" avoids the hubris that sometimes accompanies the exercise of power in the public trust. It gives us a rich portfolio of expertise to draw on. We are constantly exposed to different perspectives and are expected to explain and justify our actions to the same competent authorities in each of the member states, which is a guard against complacency and the bureaucratic mindset. This is one of the benefits of our approach, as it fosters a capacity for continuous innovation in the way we regulate. We have to be networked—it's wired into our DNA. The fact that national authorities still have a role in issuing a marketing license makes us nimble and doubly aware of how we impact public health.

TL: When I became Executive Director in January 2001, we had about 150 employees; today we have more than 850. The Agency administers a network of more than 5,400 experts distributed among 44 drug-licensing authorities in 30 countries. We manage six scientific committees responsible for our centralized authorization procedure, which is now mandatory for all new technologies, including biologics, with a seventh committee—on pharmacovigilance—in preparation. On top of that there are 35 expert working parties that supervise the development of clinical guidelines and support the preparation of dossiers.

What happened here was the political leadership in Brussels recognized that completion of the internal market required a stronger European basis for regulating the safety and efficacy of medicines. Directives were introduced in 2001 to clarify and expand our mandate in the human and the veterinary medicines area, with new scientific evaluation committees established in critical areas of unmet health needs, such as orphan drugs. Then in 2004, we had the "big bang"—the entry into our network of 10 new EU member states, followed by two more in 2007. This brought significant challenges in coping with more players at the table while maintaining the commitment to efficient dossier management and timely appraisals. We also saw the introduction of risk and surveillance management planning and the conditional approval track, where companies can gain expedited decisions on products for diseases that are severe and life-threatening and do not have substitutes on the market. Next, we had to respond to pressure to help speed the development of pediatric medicines, resulting in the creation of yet another scientific review committee. Because of the policy sensitivities and the complexity of the science, it was probably the most complicated set of rules anyone has ever had to introduce in Europe.

The Commission Regulation of 2004 also defined a role for the Agency in tracking the pace of scientific discovery to ensure our standards are relevant and supportive to what industry is seeking to deliver for patients. It resulted in legislation to create a Committee on Advanced Therapies to facilitate introduction of novel technologies, such as gene or cell therapies or tissue engineering. This is a real innovation for Europe, as no other national regulatory body has such a group dedicated to fostering timely introductions of the new medicines of the future. One of our key objectives at the Agency—in addition to certifying safety and efficacy—is to stimulate innovation and promote the availability of new medicines. Good regulation can facilitate that; the Advanced Therapy Committee is an example I am quite proud of.