The European Commission is calling for views on its plans to establish a public/private partnership (PPP) in life sciences research and innovation.Based on the success of the Innovative Medicines Initiative (IMI), the Commission is proposing to set up a life sciences PPP within Horizon 2020, its flagship, 80 billion-euro initiative which is set to run from 2014-2020 with the aim of establishing Europe's global competitiveness.
Discussing the reasons for its proposal, the Commission notes that the challenges facing the healthcare sector in Europe are very large, and include not only an ageing population and a concomitant rise in chronic and degenerative diseases, but also new infectious diseases and the spread of antibiotic resistance.
The pharmaceutical industry and the entire life science innovation ecosystem are also under increasing economic pressure, it adds. The time from a basic discovery to a new drug or vaccine becoming available for patients averages 10-15 years, and many important basic academic findings never enter the innovation cycle because of gaps in knowledge, lack of incentives or appropriate training or investments, particularly in the early stages of translation - the so-called "valley of death."
Despite the strong science base in Europe and promising research results, a number of barriers continue to discourage the private sector from translating research results into novel health services and products, not least being need for multidisciplinary solutions for medical problems, it notes, adding: "as a result, the innovative power of academia, small or medium-sized enterprises (SMEs) and large companies is underused, and innovation processes falter and happen too slowly."
Some of the specific challenges in life sciences research and innovation highlighted by the Commission are that:
- currently, not all healthcare challenges are appropriately addressed by research and innovation. Medical conditions that are considered difficult to address or where the expected return on investment is low are often left out;
- successful innovation requires the collaboration of several scientific areas and sectors. For example, a number of new pharmaceuticals are being co-developed with a diagnostic, and in future, new interventions could be co-developed with an imaging test. However, this is challenging for a variety of reasons, including differences in innovation cycles and regulatory requirements;
- in most cases, new healthcare innovations require extensive clinical testing and this poses many challenges, such as the lack of predictive power of pre-clinical toxicology testing and the fact that patient populations are not well-defined, contributing to the need for large, lengthy and expensive clinical trials. "All too often, a new pharmaceutical fails in late clinical development, after hundreds of millions of euros have already been spent for its development. Even if the clinical development can be successfully concluded, so much time and money have been invested that the process is viable for only few indications," says the Commission; and
- while fully recognising the need for ensuring patient safety, disproportionate public regulation and complex approval procedures can work against innovation in the life sciences sector. Existing regulation can prevent adaptation to changing public health needs, while regulation for completely new treatment approaches sometimes has to be drawn up from scratch, slowing the innovation process. Europe's fragmented regulatory environment risks multiplying red tape and innovation costs, it notes.
Examples of issues which the Commission believes the proposed PPP could address include a better understanding and classification of disease through a molecular taxonomy, in order to gain an improved definition of groups of patients who may or may not benefit from an intervention to be tested, and set the tools for better, earlier diagnosis and targeted treatments. In parallel, the IMI's ongoing work on developing tools for assessing the safety of compounds is very promising and could be expanded, it says.
The PPP under Horizon 2020 could also provide a neutral space for life science industries to innovate in close cooperation with regulators, it suggests, adding: "this should lead to scientific tools and methods which allow for better responses to regulatory needs, as well as to efficiently devising regulatory pathways for completely new approaches for prevention, diagnosis and treatment of diseases."