New EU initiative to support small biotech firms
favourable to big biotech companies, at the expense of smaller
firms, according to consultants within the industry.
In order to tackle this problem and provide more opportunities for small firms, new EU provisions for small biotech companies have been introduced and support to small firms is now one of the European Commission's priorities for economic growth. "The European Commission now recognises that small and medium-sized enterprises (SMEs) play a crucial role in the European economy," said Christopher Holloway, director of regulatory affairs at ERA consulting. "This can be observed in our industry as many new therapies, such as cell and gene therapies, are driven forward by SMEs." Speaking at the pharmaceutical conference Pabord in London, Holloway stressed that biotech SMEs are seen as a main source of innovation and should take advantage of the new EU regulations, introduced last December. As part of the provisions in the new pharmaceutical legislation, the European Medicines Agency (EMEA) now offers new services and reduced fees to benefit small biotech companies that use the EMEA for review and approval of new medicinal products. Biotech SMEs can benefit from a 90 per cent reduction on a number of fees payable to the EMEA, such as scientific advice, inspections, and other scientific services. Small firms also benefit from an exemption of the fee for administrative services. "One of the key advantages of the SME status is access to the scientific advice procedure at the EMEA at a greatly reduced fee, even for potentially blockbusting drugs," said Holloway. "Scientific advice procedures are an important tool in Europe during the development of medicinal products and EMEA scientific advice is now more accessible than ever to SMEs," he concluded. The European Commission defines small and medium-sized enterprises (SMEs) as firms which employ fewer than 250 persons and which have an annual turnover not exceeding €50m.
