SwedenBIO’s assessment:
The scientific advice provided by the Swedish Medical Products Agency (LMV) is of great importance for young life science companies to avoid making fundamental errors at an early stage that would be costly and laborious to correct. The fee for this advice is currently SEK 45 thousand, which is a significant sum for the companies that benefit most from the advice. The amount is significantly higher than what comparable countries charge for the same service. LMV has an important and overlooked role in the innovation system while its resources have been eroded over a long period of time.
SwedenBIO’s proposal:
- Appropriation 1:9 Läkemedelsverket, expenditure area 9, should be increased to enable the Agency to contribute to the utilization of innovation in life science in Sweden.
- Charges for scientific advice to SMEs should be reduced or, if possible, eliminated. To achieve this, Chapter 6, §4 of the Ordinance (2010:1167) on fees for the state control of medicines needs to be revised.
- An extension of the LMV’s scientific advice to medical devices should be made.
- Make the LMV responsible for official statistics in its field, e.g. to follow and disseminate information on the development of clinical studies/trials and to conduct an external analysis of this as part of the decision-making process in the area.
