The European Commission launched a public consultation to seek key views relating to the launch of a PPP in the life sciences research area under Horizon 2020 and what areas should be addressed. The planned PPP would implement part of the "health, demographic change and wellbeing" challenge. The consultation is open to all citizens and organisations, contributions from companies, organisations and researchers active in life sciences research and innovation are particularly sought. Deadline for contributions is on 04.10.2012.
>> to the public consultation
It has been well documented that with the ageing of the European population and a concomitant rise in chronic and degenerative diseases the challenges for the healthcare sector in Europe are very large. Also, in our interconnected world new healthcare challenges arise such as 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, while the time from a basic discovery to a new drug or vaccine being available for patients is in average 10-15 years. Many important basic academic findings never enter the innovation cycle because of gaps in knowledge, funding, lack of incentives or appropriate training or investment, in particular in the early stages of translation, the so-called “valley of death”.
With the new data generated in the omics era (genomics, proteomics, epigenomics, metagenomics), the paradigm changed from phenotypic definitions of disease to their molecular understanding. As a consequence, the complexity of the challenge for life science research and innovation including pharmaceutical R&I has increased dramatically in the past several years.
Despite the strong science base 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 the least being the necessity of multidisciplinary solutions for medical problems.
As a result, the innovative power of academia, small or medium-sized enterprises, and large companies is underused, and innovation processes falter and happen too slowly.
Some of the specific challenges in life science research and innovation being considered are:
- 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 research and innovation scientific areas and sectors. For example, several new pharmaceuticals are co-developed with a diagnostic. In future new interventions could be co-developed with an imaging test.
- However, this is challenging for a number of reasons including for example different innovation cycles and different regulatory requirements.
- For life science research and innovation to reach the patient and thereby the market requires in most cases extensive clinical testing. Clinical testing poses many challenges, such as the lack of predictive power of pre-clinical toxicology testing and the fact that patient populations are often not well defined. This contributes to the need for large, long lasting and expensive clinical trials. All too often a new pharmaceutical fails in late clinical development, after hundreds of millions of Euro have already been spent for its development. Even if the clinical development can be successfully concluded, so much time and money has been invested that the process is financially viable for only few indications.
- While fully recognising the need for ensuring patient safety, disproportionate public regulation and complex approval procedures can work against innovation in the life science industry. Existing regulation can prevent adaptation to changing public health needs. And regulation for completely new treatment approaches has sometimes to be drawn up from scratch, slowing down the innovation process. The fragmented regulatory environment in Europe risks multiplying red tape and innovation costs.
This public consultation is intended to enable the gathering of key views relating to the launch of a renewed PPP in the life sciences research area under Horizon 2020. The consultation also probes what areas should be addressed in a PPP under Horizon 2020 in order to address the challenges, foster collaboration among entities throughout the innovation cycle from academia to large industry, and including patient organisations and regulators, and among various disciplines.
Examples for issues to be addressed in a PPP in life sciences are a better understanding and classification of disease through a molecular taxonomy, in order to have a better definition of groups of patients who may or may not benefit from an intervention to be tested, and set the tools for better and earlier diagnosis, and targeted treatments. In parallel, the IMI ongoing work to develop tools for assessing the safety of compounds is very promising and could be expanded. The partnership under Horizon 2020 could also provide a neutral space for life science industries to innovate in close cooperation with regulators. This should lead to scientific tools and methods which allow responding better to regulatory needs as well as to efficiently devising regulatory pathways for completely new approaches for prevention, diagnosis and treatment of diseases.
The consultation also asks questions about the experience with the setup of the administrative structure of the current Joint Undertaking, the Innovative Medicines Initiative and options for implementing a PPP under Horizon 2020.
Background
Under the 7th Framework programme for research, technological development and demonstration activities (2007-2013) (FP7) the European Union entered into a public private partnership with the pharmaceutical industry, represented by its umbrella organisation European Federation of pharmaceutical industries and associations (EFPIA). The Innovative Medicines Initiative was established by Council regulation 73/2008 of 20.12.2007. Both partners contribute € 1 billion each to implement IMI. With this funding IMI is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients.
IMI supports collaborative research projects and builds networks of experts from the large pharmaceutical industry, SMEs and academia, and also involve patient representatives and regulators in order to boost pharmaceutical innovation in Europe.
IMI is implemented through projects where publicly funded consortia selected through open and competitive calls for proposals are teamed up with pre-existing consortia of EFPIA companies. The work of the EFPIA companies is the in-kind contribution of industry to the programme.
Information about the initiative can be found at the IMI website www.imi.europa.eu. As of now there are 30 ongoing IMI projects, many of which are producing remarkable results, such as the generation of the first human pancreatic beta cell-line as a tool for drug discovery in diabetes (IMIDIA project) or the creation of the largest ever database of results of clinical trials in schizophrenia, bringing together data from 23000 patients and allowing a significant improvement of the design of clinical trials in this area (NEWMEDS project).
Further information and online questionnaire under:
http://ec.europa.eu/research/consultations/life_science_h2020/consultation_en.htm
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