Special Provisions for SMEs
The majority of companies active in the biopharmaceutical sector are Small and Medium-sized Enterprises (SMEs) and these merit particular attention. If patients and society are to benefit from the advances being made by these companies, the business climate also needs to ensure that they can be successful. If there is a failure of the business environment to foster a healthy biopharmaceutical SME sector, there is a risk that the full potential of the biopharmaceutical revolution will not be realised. Biotechnology companies are reinvesting more than half of their revenues straight back into finding more healthcare solutions. Thus, when revenues increase, so does investment in research and development for new treatments.
To guarantee that patients continue to benefit from this reinvestment, it is important to create and support the right environment for biotech companies.
EBE participate on this process by both supporting the business development of member companies, and fostering a good regulatory environment that will allow SMEs to receive proper support by the EU authorities.
Accordingly to the European Commission Recommendation 2003/361/EC, that entered into force on 1st January 2005, a company is considered an SME when it:
· Has fewer than 250 employees; and
· Either a turnover of less than 50 million Euros
OR
· A balance sheet of less than 43 million Euros
With Regulation (EC) No 2049/2005, related to SMEs, the European Commission has adopted significant fee reductions and deferrals for a number of EMA services, such as scientific advice.
Key measures of the European Regulation are:
- 90% reduction on a number of fees payable to the EMA, such as: scientific advice, inspections, and other scientific services;
- Exemption of the fee for administrative services;
- Deferral of the fee for the marketing authorization application until the end of the evaluation procedure;
- Conditional fee exemptions where scientific advice has been sought and effectively implemented;
- A system for outsourcing translations of the documents required for the granting of the marketing authorization;
The EMA has also officially opened their SME Office to offer administrative assistance, facilitate communication and answer enquiries. More information on the functioning of the SME Office is available on the EMA Website at http://www.ema.europa.eu/SME/SMEoverview.htm