What are the key priorities of the 2015 road map?
TL: Final action on this awaits the decision of the Management Board, which meets this month and is slated to endorse both the
road map and an accompanying "Vision to Reality" white paper. I would summarize the priorities to 2015 as follows: 1) maintain
our core mission in approving new products through the European Regulatory Network; 2) fill gaps in the development of medicines
for urgent health needs, such as antibiotics and the diseases of aging, and work with industry to address high attrition rates
for many therapies; 3) adapt regulatory capacity to manage the growth of personalized medicine, through such means as setting
standards for the qualification of biomarkers in cancer; 4) improve the scope of legislation covering veterinary medicines
and find better ways to create synergies with our work in the human field; and 5) create a stronger preparedness/alert platform
to manage public health crises as well as control the distribution of counterfeit drugs. There is a lot of continuation here,
which is good, as we are building on success.
As we look to the future, what do you think are the most important trends that will influence the actions of regulators like
yourself, particularly in the relationship with the R&D industry?
TL: Globalization represents a real game change for the regulator. The perception has been that there is a fixed geographic limit
to our mandate. But over the last decade we have discovered that the products we regulate are researched in numerous sites,
involving parties with different levels of skill or expertise; are subjected to clinical trials among increasingly diverse
patient populations, in dozens of different countries; and are manufactured outside our territory, based on active ingredients
formulated increasingly in China and India. The fundamental question is, Can we trust that all this critical work done outside
our "span of control" is safe, reliable, and in conformity to our rules?
So how are you responding? Are you following the FDA lead and establishing a direct physical presence in markets outside Europe?
TL: No. We are not choosing to do that. Part of our strategy is to focus on executing bilateral agreements, the most important
of which is the confidentiality arrangement and implementation plan we now have with the FDA. What is valuable about these
agreements is that they facilitate structured contacts and lots of dialogue. For example, I have a representative of the FDA
in an office 20 feet away from my own, and just down the hall we have an executive from Japan's PMDA. Our people are located
at the FDA as well.
We have also identified the quality and consistency of clinical trials conducted outside Europe as a key area for action.
The Agency sponsored a successful conference on this issue in September, a reflection paper is being published, and on this
basis we will develop the necessary regulatory framework. The goal is to guarantee that such trials are conducted on patients
that are representative of the European population and follow our accepted ethical and quality standards.
A third priority is improving the process of consultation to bring in new countries beyond the triad of the US, Europe, and
Japan. The International Conference on Harmonization (ICH) is a good vehicle. The ICH Global Collaboration Group and associated
Regulators Forum is the focal point for bringing most of the emerging markets into the fold. That is now taking place. The
next step is deciding what we want to do as a larger group. In my view, there are two priorities: 1) sharing information,
in the context of confidential agreements between all the regulatory agencies, and 2) promoting the widest possible acceptance
of ICH practice agreements—GCP, GMP, and the like. This latter objective is critical for avoiding duplication of effort as
more countries seek to regulate in these areas.
I also think it important to consider carefully the right platforms for cooperation. Earlier this autumn, we had a fifth summit
of national regulatory chiefs in the UK. It was originally launched on the initiative of former FDA Commissioner Andrew von
Eischenbach. Some 22 of us sat around a table and discussed issues, with no publicity or staff support, and a very loose agenda.
I think this is a very productive model in sharing how we can cope with the pressures of globalization.