European companies believe that government cost containment measures have damaged the region's competitiveness, and point to R&D investment figures as evidence. In 1990, pharmaceutical R&D investment in the US was less than in Europe; however, R&D investment in Europe now is only approximately 70% of the US figure.1 Between 1990 and 2008, R&D investment in the US grew by 5.6 times compared with 3.5 times in Europe.1 To compound the situation, Europe also faces competition from further afield because of the rapid growth in the research environment in emerging economies, such as China and India. The European Federation of Pharmaceutical Industry Associations (EFPIA) has expressed its concern that this trend has led to the closure of European R&D sites.
Government policies alone, however, cannot be blamed for the difficult R&D conditions. Because of the inherent risks of drug development, many companies have adopted a conservative attitude to using new technologies that may add extra risk to the process, but the steady decline in new drug output suggests that this cautious approach is undermining innovation. However, although there is recognition that bottlenecks exist in the current R&D process, few solutions have been found to ease them.EFPIA's analysis of the period 2004 to 2008 shows that, while European companies have experienced a decline in new drug output, their US counterparts have become the world leading inventors of new molecules.1 This trend is worrying — particularly as the US pharma industry has expressed frustration at its own low level of innovation!2,3 Similarly, the emerging markets of China and India are also considered to be far from optimal environments for R&D.4,5
The Innovative Medicines Initiative
Many in the industry believe that there is no reason why Europe should not be able to keep pace with the US, given the existence of highquality research resources. Many also believe that the way to reinvigorate Europe's R&D lies in a collaborative approach, featuring both public and private parties. This thinking has led to the development of the Innovative Medicines Initiative (IMI), a public–private partnership designed by the European Commission (EC) and EFPIA, to find clear, practical paths to accelerating drug development and stimulate regional R&D.6 The initiative's Strategic Research Agenda will centre on addressing the problems identified with regional R&D by fostering collaboration across the region. This cooperative approach should reduce the risks for all those involved — particularly small companies.
The IMI's governing body is composed of ten board members — five from EFPIA and five from the EC, representing the European community. Although the IMI does not have a specific membership structure, it has a pan-European focus, with stakeholders across the region being eligible to participate in research. Once a year, the IMI also holds a stakeholder forum to disseminate information on activities and give participants the opportunity to provide input on the future direction of the organisation. In addition, the IMI holds consultative workshops with work through associations that represent participants concerned; for example, to better serve small companies, the IMI has said it will work with the European Biopharmaceutical Enterprises and EuropaBio.
The operation of the IMI is similar to that of a nonprofit organisation, with research grants being awarded to European public–private collaborations. While public money will be used to fund academic and patient participation and support SMEs, large biopharmaceutical companies will fund their own contributions.
The IMI has already identified the R&D bottlenecks as predicting safety, predicting efficacy, bridging gaps in knowledge management, and bridging gaps in education and training. From data collected, it was found that the likelihood of a drug candidate reaching the market was <6%.6 The most common factors for failure were lack of efficacy (25%), clinical safety concerns (12%) and toxicological findings in preclinical evaluation (20%).6 The best way to avoid these problems is to predict failure at the earliest stage possible in the R&D process, which necessitates placing greater importance on predictability and not becoming too dependent on promising preclinical data.
Between 1990 and 2001, predictability in the R&D process was enhanced through the development of drug metabolism studies. With time, invitro absorption and metabolism screens were validated by correlation with clinical data. The IMI aims to achieve similar clinical correlations for the factors that have been identified as the major causes of attrition. To do this, it is supporting panEuropean public and private sector collaborations so the research is not focused on products themselves, but generates tools, information and data that can be used by all companies. In this way, it is hoped that companies will be not be averse to their competitors having equal access to the results, as they stand to benefit from the outputs and sensitive product data are not being shared.