Medical Regulatory Affairs Today

European Medicines Agency (EMA) – The SME Register

Blog41_photoIncentives for micro, small and medium-sized enterprises (SMEs)

Micro, small and medium-sized enterprises (SMEs) play a vital part in the European Healthcare Industry. They are an excellent source of entrepreneurial skills, innovation and employment. Within the European Union, approximately 23 million SMEs provide 75 million jobs across all industries.

  • Micro enterprises are defined as enterprises which employ fewer than 10 people and who have an annual turnover or an annual balance sheet total which does not exceed €2 million.
  • Small enterprises are enterprises which employ fewer than 50 persons, and who have an annual turnover or an annual balance sheet total which does not exceed €10 million.
  • Micro enterprises are defined as enterprises which employ fewer than 250 people and who have an annual turnover sheet total which does not exceed €50 million and/or a balance sheet total not exceeding €143 million.

Unfortunately, SMEs are frequently forced to overcome market imperfections, rarely experienced by larger companies. SMEs often face difficulties in obtaining capital or credit particularly in the early set up phase. They also have restricted resources, reducing their access to new technology or innovation. Acknowledging these challenges, the European Commission (EC) prioritised their support for SMEs, in an attempt to increase economic growth.

A common definition, listing the measures in favour of SMEs, is in place with aims to improve consistency and effectiveness. The first common SME definition was adopted by the EC in 1996. Since then a revised definition has been adopted by the EC to capture new economic developments. This revised definition, EU Recommendation 2003/361/EC, was applied from 1st January 2005, and applies to all policies, programmes and measures that the commission operates for SMEs.

The SME Register, launched by the European Medicines Agency (EMA) in 2010, was created in consultation with SME stakeholders with the following objectives:

  • To facilitate and promote innovation, partnering and networking between SMEs
  • To increase information available to SMEs and their stakeholders
  • To provide a source of information for European Union (EU) institutions, agencies and member states.

The EMA has implemented EC Regulation No 2049/2005 by providing incentives for SMEs that are developing and marketing medicines for human and veterinary use. In line with this regulation, the EMA register implements it’s ideals on such companies. Some of the incentives offered by the EMA include:

  • Administrative and procedural assistance from the SME office
  • Fee reductions for pre-submission scientific services
  • Assistance with translations of the product information documents submitted in the application for marketing authorisation.

To establish the eligibility of a company for SME incentives, the EMA provides the following criteria under EC recommendation 2003/361/EC;

  • Considered an enterprise (‘any entity engaged in an economic activity, irrespective of its legal form‘)
  • Be established in the European Economic area

The EMA Register of SMEs is a useful source for SMEs looking to benefit from the measures introduced by the European, national, regional and local authorities according to the latest definition. If necessary, further refinements may be made to the latest definition, and the Commission will adapt it in the coming years to take account of experience and economic developments in the European Union.