Finland Will Increase Executive Powers in Relation to Medicines and Medical Devices to Tackle Medicine Shortages in Health Crises
In early May 2020, Finland notified to the European Commission (the “Commission”) a series of proposed measures to tackle medicine shortages (see, attached notification). The notification, based on Directive (EU) 2015/1535 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services, should allow the Commission and other Member States to offer their view on the compatibility of the proposed measures with EU pharmaceutical law and with the free movement of goods principle.
The Finnish government submitted to Parliament a draft Law which, if adopted, will amend a series of existing laws as follows:
- The Ministry of Social Affairs and Health will have the power to restrict the distribution, sale and release for consumption of medicines. It will also be able to prioritise the distribution of specific medicines or impose a range of usage conditions. Additionally, flanking measures will make it easier for the Ministry to enforce these new powers.
- The Finnish Medicines Agency and the Ministry of Social Affairs and Health will be given broader powers to run mandatory reserve supplies of medicines by, for example, requiring these supplies to be located in Finland.
- The Ministry of Social Affairs and Health will have more powers to tackle communicable diseases, both with regard to medicines preventing such diseases or treating related conditions and with regard to medical devices for which no conformity assessment has yet been issued.
While the outbreak of Covid-19 has prompted this initiative, the Finnish government expressly seeks to bolster executive powers to tackle other health crises as well. It points out that Finland is particularly vulnerable given its dependency on imported medicines.