Small- and medium-sized companies (SMEs) are innovation powerhouses and drivers of economic growth in Europe. They represent 99.8% of EU enterprises and generate 85% of new jobs in the private sector. When the EMA looked at the origin of new medicines authorised from 2010 to 2012, it found that 27% of all new medicines and 61% of medicines for orphan indications and rare diseases originate from SMEs. In order to remain competitive internationally, innovative biotech SMEs, with long product development times in particular need public policy support.
One key aspect is greater access to collaborative research initiatives in Europe, and this is where Public-Private Partnerships become so relevant. The Innovative Medicines Initiative, IMI, is a real life example of such open collaboration efforts, that is starting to bear fruit and offer a new path for innovation in the EU.
IMI projects see the pharmaceutical industry working together with universities, hospitals, small- and medium-sized enterprises (SMEs), patient organisations and public authorities; including regulatory bodies. Projects cover a wide spectrum of challenges, from early to late stages of medicines development; from biomarkers for vaccine safety to understanding chronic pain and developing anti-tuberculosis drug combinations. By October 2017, IMI projects have already produced 2686 high-impact publications – in fact, IMI scientific publications have a citation impact that is nearly twice the EU average.
IMI’s aim is to tackle bottlenecks in drug development and confront areas of healthcare need that are of high priority to society, while improving the drug development process through more efficient discovery. It does this by developing better and safer medicines for patients through sharing data, pooling resources and exchanging expertise.
Learn more about IMI: www.imi-europa.eu
Current Call for Projects: Call 17: https://www.imi.europa.eu/apply-funding/open-calls/imi2-call-17
Incentives, IP and smaller companies:
Public policy offers a variety of incentives to stimulate innovation. A trusted tool in any innovative industry branch is the protection of intellectual property (IP; see here for our thoughts on IP).
However, there are additional, important incentives offered by the legislation that regulates medicines in Europe. Below, some of our members explain how incentives and IP help bring innovative products to patients, but also how important they are to smaller companies in their development. The EBE President, Eduardo Bravo also explained the need for incentives in the 25 September 2017 issue of the European Parliament Magazine – see here.
Access to finance:
Despite such important funding of research, access to finance remains a constant issue for innovative SMEs in biopharma. In 2015, the European Federation of Pharmaceutical Industries and Associations (EFPIA) asked Charles River Associates (CRA) to investigate the extent to which there are barriers to the growth of biopharmaceutical companies in Europe and the extent to which companies of different sizes face different challenges in raising capital to fund research and development (R&D).
Although there is a large amount of literature on the competitiveness and growth of micro, and small- and medium-sized enterprises (SMEs) in Europe, particularly those investing in early-stage research, there has been little focus to date on how companies grow and whether similar challenges exist for innovative firms of a larger size, which are engaged in the far more costly, later stages of product development. The CRA report is available here, and was considered in the development of an EBE Position Paper on the funding of the European biotech ecosystem (available here). The CRA findings were also presented at the European Medicines Agency roundtable with stakeholders on the 10-year anniversary of the Micro-, small- and medium-sized-enterprise (SME) office – see here.